drugset / Trial / NCT00491920

High Dosage Vitamin D and Osteoporosis

NCT00491920

RandomizedSingle-groupQuadruple-blindTreatment

Summary

Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women with T-score \<= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week, while the other half will have placebo. The study period is one year.

Timeline

Start
2007-02
Primary completion
2010-02
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Cholecalciferol Other / unclassified 400 iu
Subject Cholecalciferol Other / unclassified 20000 iu
Background Calcium carbonate Other / unclassified 500 mg

Indications